Amlodipine Besylate and Atorvastatin Calcium Tablets 2.5mg/10mg
Composition:
Each tablet contains:
- Amlodipine Besylate equivalent to Amlodipine 2.5mg
- Atorvastatin Calcium equivalent to Atorvastatin 10mg
Description:
Amlodipine is a calcium channel blocker (CCB) that relaxes blood vessels and improves blood flow, helping to lower blood pressure.
Atorvastatin is a statin (HMG-CoA reductase inhibitor) that reduces cholesterol levels and lowers the risk of cardiovascular diseases.
Indications:
This combination is used for the management of hypertension, angina, and dyslipidemia, particularly in patients requiring both blood pressure control and lipid-lowering therapy. It is indicated for:
- Hypertension (high blood pressure)
- Chronic stable angina and vasospastic angina
- Hypercholesterolemia and mixed dyslipidemia
- Prevention of cardiovascular events in high-risk patients
Dosage & Administration:
Adults:
- Usual dose: 1 tablet once daily, with or without food
- Dose adjustment: Based on clinical response
- Maximum dose: Amlodipine 10mg/day, Atorvastatin 80mg/day
Renal Impairment:
- No dose adjustment required.
Hepatic Impairment:
- Use with caution; contraindicated in active liver disease.
Contraindications:
- Hypersensitivity to Amlodipine, Atorvastatin, or excipients
- Active liver disease or unexplained persistent elevations in liver enzymes
- Pregnancy and breastfeeding
- Concomitant use with strong CYP3A4 inhibitors (e.g., clarithromycin, itraconazole)
Precautions:
- Liver Function: Monitor liver enzymes before and during treatment.
- Muscle Toxicity: Risk of myopathy, rhabdomyolysis; discontinue if muscle pain or weakness occurs.
- Hypotension Risk: Caution in patients with severe aortic stenosis.
- CYP3A4 Interactions: Avoid grapefruit juice and certain medications that increase Atorvastatin levels.
Adverse Reactions:
- Common: Headache, dizziness, peripheral edema, flushing, fatigue
- Gastrointestinal: Nausea, abdominal pain, constipation
- Musculoskeletal: Myalgia, muscle cramps
- Hepatic: Elevated liver enzymes (rare)
- Serious (rare): Rhabdomyolysis, acute renal failure, severe hypotension
Drug Interactions:
- CYP3A4 inhibitors (e.g., ketoconazole, erythromycin): Increased Atorvastatin levels
- Grapefruit juice: May increase the risk of muscle toxicity
- Digoxin: Amlodipine may increase digoxin levels
- Antihypertensive agents: Increased blood pressure-lowering effects
- Warfarin: Atorvastatin may slightly enhance anticoagulant effects
Storage Conditions:
- Store below 25°C, in a dry place, away from light.
- Keep out of reach of children.
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